The Global Pharmaceutical Industry Must Play a Key Role in AMR Mitigation

Antibiotics are essential medicines that have revolutionized modern healthcare, but the rise of antimicrobial resistance (AMR) is threatening their effectiveness. Antibiotics have delivered a major impact on global life expectancy at birth; it is estimated that they may save up to 200,000 lives annually in the United States of America alone.

However, the rise of antimicrobial resistance, when microbes develop mechanisms to protect them from the effects of antimicrobial drugs such as antibiotics, risks the very foundation of our global gealth systems. Today, AMR is already one of the top 10 global public health threats, and it is likely to get worse. The United States Agency for International Development (USAID) estimates that drug-resistant infections in humans and animals can kill up to 10 million people a year and cost economies a staggering $100 trillion by 2050 if multi-sectoral actions are not deployed expeditiously. Such drastic consequences require mitigating all of AMR’s drivers, which simultaneously contribute to the spread and emergence of resistance in humans and animals. Resistance can come from many sources, including overuse or misuse of antibiotics in humans, animals, agriculture, and aquaculture, poor infection control, lack of basic sanitation, inadequate waste infrastructure, and from antibiotics that enter the environment through processes like antibiotic manufacturing, among other factors.

Fortunately, there is a path forward, but it requires coordinated and multi-sectoral actions from different stakeholders like agricultural and livestock communities, healthcare facilities, regulators, pharmaceutical manufacturers, and procurers, amongst others. This widespread coordination is in line with the One Health approach – the basis of many national and global action plans – which acknowledges the interconnections between human and animal health, agriculture, and the environment, and recommends coordinated actions to protect the same. While there have been concerted actions to limit the drivers of AMR in the animal, human and agricultural sectors, there is still a lot to do to mitigate AMR in the environment.

Here, the global pharmaceutical sector has a vital role to play. Environmental regulations typically do not address antibiotic concentrations in waste streams. Given the scale of antibiotic production worldwide, it is imperative that pharmaceutical manufacturers apply effective controls to minimize antibiotic emissions in waste streams, thus reducing the risk of AMR developing in the environment in proximity to production locations. To best ensure effective control of antibiotic emissions from pharmaceutical production, the AMR Industry Alliance (AMRIA), the largest life-sciences coalition created to provide sustainable solutions to curb AMR, and British Standards Institution (BSI) launched a manufacturing standard and forthcoming certification scheme. This effort will provide independent certification to stakeholders in the global antibiotic supply chain. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent verification scheme.

Many leading antibiotic manufacturers have already demonstrated adherence to the Alliance’s expectations for effective control of antibiotic emissions, as reported in the Alliance’s latest report. For example, companies like Centrient Pharmaceuticals, have deployed stringent practices in manufacturing units the world over, including in India. While there has been an increase in the incidences of antibiotic pollution of river and water bodies in India, the company has prioritized limiting and detecting antibiotic residues in their wastewater. In 2022, the company publicly disclosed that it met the safe discharge targets of the Alliance’s manufacturing standard for its entire oral antibiotic product range. The AMR Industry Alliance calls on all antibiotic manufacturers to commit to achieving certification for their products against the antibiotic standard.

The pharmaceutical industry has been the enabler of our modern healthcare systems. The repercussions of the COVID-19 pandemic could have been much more adverse if the global pharmaceutical community did not come together in the development of vaccines and other medications. Rising AMR, often dubbed as the silent pandemic, cannot be effectively mitigated without the contribution of the pharmaceutical industry. At the same time, the government should also understand the criticality of limiting the build-up of AMR in the environment and strike a balance between regulations and business enablement.